1. Field of the Invention
The present invention relates, in general, to an appliance for use with a stoma, and, more specifically, to such an appliance that forms a seal about the stoma and that includes one or more accessories to control the passage of air therethrough.
2. Information Disclosure Statement
A laryngectomee patient will frequently wear a foam filter pad and a shower shield to protect the opening, or stoma, in the patient""s throat through which the patient must breathe. Although the filter pad and shower shield functions adequately, it does present several problems. In rainy weather, the pad must be protected from getting wet. Coughing fluid from the patient""s lungs necessitates frequent changing of the pad, and water typically enters around the sides and top of the shield when the patient turns his head while showering. Laryngectomee patients have long needed a device that adequately helps to prevent water from entering the stoma.
A preliminary patentability search conducted in class 128, subclasses 207.17, 207.16 and 207.14, produced the following patents which appear to be relevant to the present invention:
Tabor, U.S. Pat. No. 3,137,299, issued Jun. 16, 1964, discloses a tracheotomy tube having a valve designed to enable the patient to expel bronchial secretions by coughing.
Birch et al., U.S. Pat. No. 3,827,440, issued Aug. 6, 1974, discloses a removable check valve for installation on the external portion of a tracheotomy tube.
Tabor, U.S. Pat. No. 4,325,366, issued Apr. 20, 1982, discloses a tracheotomy tube with a valve designed to allow air to flow in either direction responsive to normal breathing through the tracheotomy tube while blocking air flow out the tracheotomy tube responsive to air flow above that present in normal breathing. A shower shield and filter can be used with the valve.
Andersson et al, U.S. Pat. No. 4,971,054, issued Nov. 20, 1990, discloses a breathing valve designed to filter an control the humidity of air inhaled via tracheotomies and tracheal tubes.
Eliachar et al., U.S. Pat. No. 5,048,518, issued Sep. 17, 1991, discloses a stoma stent system including a tubular stent for insertion into a trachea, and several plug components for insertion into an open end of the stent to progressively constrict air flow through the stent, transfer moisture from exhaled air to inhaled air, or redirect exhaled air toward the vocal cords, etc.
Coe et al., U.S. Pat. No. 5,059,208, issued Oct. 22, 1991, discloses a patient adjustable valve to control the flow of air through a stoma in the neck of the patient.
Friberg et al., U.S. Pat. No. 5,201,309, issued Apr. 13, 1993, discloses a housing for holding a replaceable laryngotomy tracheostomy filter, and a hood having a downwardly directed suction channel through which inhaled air has to pass before it reaches the filter.
Huchon et al., U.S. Pat. No. 5259,378, issued Nov. 9, 1993, discloses a tracheotomy device comprising a tracheotomy cannula, a non-return valve for permitting inhalation flow only, means connecting to a forced oxygenation device upstream of the valve, and two filter elements upstream of the valve.
Bezicot, U.S. Pat. No. 5,487,382, issued Jan. 30, 1996, discloses a tracheotomy filter device including a filter mass and a grill designed so that most mucus expelled from the trachea is prevented from reaching the filter mass.
Persson, U.S. Pat. No. 5,738 095, issued Apr. 14, 1998, discloses a tracheostoma device comprising a filter housing for receiving a moisture and heat exchanging filter and having a valve member spring biased to an opened position and adapted to be manually closed by means of a finger applied against the spring bias.
Bare et al., U.S. Pat. No. 5,806 515, issued Sep. 15, 1998, discloses an oxygen adapter for delivering low volume supplemental oxygen to tracheotomized patient using a conventional tracheostomy speaking valve.
Smith, U.S. Pat. No. 5,848,590, issued Dec. 15, 1998, discloses a tracheostoma filter comprising a housing and a filter component movable as a result of a pressure difference due to breathing between an inhalation position and an exhalation position, resulting in a change in resistance to breathing through the filter.
Nothing in the known prior art discloses or suggests the present invention. More specifically, nothing in the known prior art discloses or suggests a stoma appliance including (a) a protective cover for attachment to the patient""s neck about the stoma, the protective cover having an aperture therethrough for positioning over the entrance of the stoma; (b) a housing member including a stoma tube for extending through the aperture in the protective cover and in the entrance of the stoma; and (c) a gasket for forming a seal between the protective cover and the housing member.
The present invention provides a solution to numerous problems experienced by laryngectomee patients. A basic concept of the present invention is to provide a substantially waterproof appliance for covering a stoma and for allowing the passage of air through the stoma to be controlled.
The stoma appliance of the present invention includes, in general, (a) a protective cover for attachment to the patient""s neck about the stoma, the protective cover having an aperture therethrough for positioning over the entrance of the stoma; (b) a housing member including a stoma tube for extending through the aperture in the protective cover and into the entrance of the stoma; and (c) a gasket for forming a seal between the protective cover and the housing member.
One object of the present invention is to provide a stoma appliance, including a protective cover and a housing member that can be removably sealed together.
Another object of the present invention is to provide a stoma appliance that is enclosed in a single unit with a filter that can be changed at anytime.
Another object of the present invention is to provide such a stoma appliance that has a chamber to hold mucus expelled from the patient""s lungs.
Another object of the present invention is to provide such a stoma appliance that will filter the incoming air and, in so doing, will reduce heat and moisture and screen objects such as dust, dirt, bugs and other small particles.
Another object of the present invention is to provide such a stoma appliance that is sufficiently water proof so that the patient can shower with little or on problem.
Another object of the present invention is to provide a tracheostoma breathing aid for laryngectomee patients.
Another object of the present invention is to provide such a stoma appliance that has replaceable filters.
Another object of the present invention is to provide such a stoma appliance that has a drain tube, an oxygen tube and a clean-out tube at the bottom or lower end thereof.
Another object of the present invention is to provide such a stoma appliance that eliminates the necessity of having tubes inserted through the patient""s nostrils.
Another object of the present invention is to provide such a stoma appliance that sticks on and may be removed easily.
Another object of the present invention is to provide such a stoma appliance that allows easy oxygen supplementation.
Another object of the present invention is to provide such a stoma appliance that allows great airflow into the patient""s lungs.
Another object of the present invention is to provide such a stoma appliance that helps hospitalized laryngectomee patients avoid numerous hookups.